Sofia Strep A FIA Field Study

Quidel Corporation2,090 enrolled

Overview

The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.

Study Type

OBSERVATIONAL

Enrollment

2,090

Conditions

Group A Streptococcus Strep Throat

Interventions

In Vitro Diagnositc aid for diagnosisDEVICE

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Presence of sore throat * Redness of the posterior pharyngeal wall * Tonsillar exudate * Tonsillar swelling * Tender anterior cervical adenopathy * Fever, \> 38º C (100.4ºF) at presentation or within past 24 hours Other symptoms that may be present, in addition to above symptoms for GAS: * Rash, typical of scarlet fever * Abnormal tympanic membranes * Palatal petechiae Exclusion Criteria: * Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study. * At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Locations (8)

La Costa Pediatrics

Carlsbad, California, United States

Santo Nino Medical Clinic

Panorama City, California, United States

La Jolla Pediatrics

San Diego, California, United States

Teena Hughes, MD

Tampa, Florida, United States

Data from ClinicalTrials.gov

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